A Clinical Trial Study of Knee System in Primary Total Knee Arthroplasty in China
A Prospective, Randomized, Multicenter, Controlled Study Comparing the Outcomes of Primary Total Knee Arthroplasty Devices Manufactured in China Versus Devices Manufactured Outside of China
1 other identifier
interventional
160
1 country
9
Brief Summary
A clinical trial of total knee system used in Primary Total Knee Arthroplasty in China.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2017
Typical duration for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2015
CompletedFirst Posted
Study publicly available on registry
March 26, 2015
CompletedStudy Start
First participant enrolled
August 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 25, 2019
CompletedNovember 18, 2019
November 1, 2019
1.9 years
March 20, 2015
November 15, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
12-month post-op AKS
12 months postoperatively
Secondary Outcomes (6)
Non-revision rates(revision for any reason) through the end of the study
12 months postoperatively
One year non-revision rate where revision is defined as removal of any component secondary to infection
12 months postoperatively
American Knee Society Total Score success (where success is defined as a score of 80 points or higher)at the 1 year follow-up inerval
12 months postoperatively
Short-form 12(SF-12) general health questionnaire each of 8 dimensions and the overall Physical and Mental health domains, at 1-year follow-up interval.
Preoperation to12 months postoperatively
WOMAC scores at the 1-year follow-up interval
Preoperation to12 months postoperatively
- +1 more secondary outcomes
Other Outcomes (2)
The proportion of Composite Successes in each treatment group will be assessed at the 1year follow-up interval
12 months postoperatively
Blood samplets will be collected and data will be summarized
pre-operative and immediate post-operatively
Study Arms (2)
Total Knee System made in China
EXPERIMENTALPatinet in this arm will be implanted with Primary Total Knee Arthroplasty Devices Manufactured in China
Total Knee System made outside of China
ACTIVE COMPARATORPatient in this arm will be implanted with Primary Total Knee Arthroplasty Devices Manufactured Outside of China
Interventions
SIGAMA PS FEMUR; TIB tray Cem Cocr; SIGAMA STAB XLK INS; PFC SIG ROUND DOME PAT 3PEG
SIGAMA PS CEM FEM; PFC MOD TIB TRAY NP; SIGAMA STAB XLK INS; PFC SIGAMA/RD/DOME PAT
Eligibility Criteria
You may qualify if:
- The subject is ≥18years old
- The Subject must be of Chinese ethnic descent and be willing to return on three occasions for clinical evaluations.
- Subject is a suitable candidate for cemented primary TKA using the devices described in this CIP with either resurfaced or non-resurfaced patellae.
- Subject must meet all criteria specified in BOTH China Knee stem and P.F.C.® Sigma knee instructions for use (IFU)
- Before surgery, subject is willing and able to sign the informed consent form approved by the Institutional Review Board (IRB), Ethics Committee (EC) or Ethical Review Board (ERB).
- Subject, in the opinion of the Clinical Investigator, is able to understand this clinical investigation and co-operate with investigational procedures.
- Subject must be comfortable with speaking, reading, and understanding questions and providing responses in an available translated language for the patient reported outcomes (PROs) in the CIP.
- Subject is receiving a unilateral knee replacement or, if a contralateral knee replacement is anticipated, the surgery must occur within 6 months of the first study knee TKA. The second knee will not be enrolled in the study.
You may not qualify if:
- Subject does not provide written voluntary consent to participate in the clinical study.
- The Subject is a woman who is pregnant or lactating.
- Subject is anticipated to require a contralateral TKA between 6 months and 1 year.
- Contralateral knee has already been enrolled in this study.
- Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee.
- Subject has a malignant disease, severe condition, alcohol or drug addiction and/or mental disorders that the investigator believes will interfere with the study participation.
- Subjects with severe osteoporosis, metabolic bone disease, radioactive bone disease or tumor in bone surrounding knee joint that, in the opinion of the investigator, will negatively impact implant fixation and the outcome of the investigation
- Subject has significant neurological or musculoskeletal disorders or disease that may adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis, cerebral infarction, hemiplegia, Charcot disease).
- Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available translated language for the PROs in the CIP.
- Subject has a medical condition with less than 2 years of life expectancy.
- The Subject has comorbid condition(s) that could limit the Subject's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study.
- The Subject is currently participating in another investigational drug or device study.
- Subject is a prisoner.
- The Subject has a known allergy to any implant components (metal for example).
- Hemoglobin \< 11 g/dL
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
General Hospital of Guangzhou Military Command of PLA
Guangzhou, Guangdong, China
Xiangya Hospital Central South University
Changsha, Hunan, China
The affiliated hosoital of Ningxia Medical University
Yinchuan, Ningxia, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Xijing Hospital
Xi’an, Shanxi, China
The West China Hospital of Sichuan University
Chengdu, Sichuan, China
The First Teaching Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fuxing Pei
The West China Hospital of Sichuan University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2015
First Posted
March 26, 2015
Study Start
August 17, 2017
Primary Completion
July 10, 2019
Study Completion
October 25, 2019
Last Updated
November 18, 2019
Record last verified: 2019-11